Mindfulness versus Cognitive Behavioural Therapy in Tinnitus patients - A Randomized Controlled, Non-Inferiority Trial
Recruiting
- Conditions
- Tinnitus
- Registration Number
- NL-OMON25150
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
Inclusion Criteria
Willingness and ability to participate in group therapy
-Dutch language proficiency
-18 years or older
-Suffering from tinnitus for at least 6 months.
-A score of =32 on the TFI
Exclusion Criteria
-Mentally incapable patients
-Patients who have already been treated for tinnitus with CBT or MBCT
-Presence of any instable psychiatric condition within 1 year before start of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to determine whether MBCT is non inferior to CBT in tinnitus burden (TFI) reduction , in adults with chronic tinnitus at 12 months. Non inferiority will be declared if the mean decrease in TFI score for MBCT is no worse than the mean decrease in TFI score in CBT, with statistical variability, with a margin of 13 points
- Secondary Outcome Measures
Name Time Method Secondary objectives are to assess change in <br>-Tinnitus severity (severity of problem & intrusiveness) <br>-Quality of life <br>-Anxiety and Depression<br>-Symptoms of psychopathology <br>-Mindfulness awareness <br>-Perceived tinnitus complaints<br>-Coping style<br>We expect non inferiority for all secondary outcomes, but one: ‘mindfulness awareness’. In mindfulness awareness we expect a superiority in the MBCT, compared to the CBT.